12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Insufflator (OPTO-IFL1000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630506·CoRoent Ant TLIF Ti, 13x11x34mm 12°
BD BBL™ Sensi-Disc™ Oxytetracycline 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313428·BD BBL™ Sensi-Disc™ Oxytetracycline 30 µg
Sklar®
FDA UDI
SKLAR CORPORATION·10649111172281·SKLHN STEVENS TENOT CVD 4.5"
HANAROSTENT Trachea/Bronchium (CCC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
FDA 510(k)
FDA Class 2
·Physical Medicine
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 18, 2011
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014
ANESTHESIA DELIVERY UNIT
FDA Adverse Event
Injury
·GE HEALTHCARE FINLAND OY·Product code BSZ·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025